Distensible bag catheter



Jan. 28, 1941. G. l.. wlNDER DISTENSIBLE BAG CATHETER Filed Oct. 15,1957 i 2/Farm., 5E @ge-Madea Patented Jen. 28, 1941 UNITED STATESDISTENSIBLE BAG CATHETEB George L. Winder, Cuyahoga Falls, Ohio,aslignor to American Anode Inc.. Akron, Ohio, a corporation of DelawareApplication October 13, 1937, Serial No. 168,756

3 Claims.

This invention relates to rubber surgical accessories and especially tocatheters provided with distensible bags of the type designed for use incontrolling hemorrhage-- following transl urethral resection of theprostate gland, and for analogous purposes, and to methods ofmanufacturing such surgical accessories.

There is now available upon the market a distensible bag catheter knownas the Foley" cathl eter which consists of a principal drainage tubeprovided with a circumferential bag portion proximal to the drainageeyelets, and having an independent distension duct extendinglongitudinally through the body of the drainage tube to l5 the bag forinjecting fluid to distendqthe bag after the catheter is in place. Suchcatheters have been made by depositing rubber from a liquid rubbercomposition upon suitable forms to produce the double-channeled body ofthe catheter, then treating a local circumferential zone of the bodywhere the distensible bag is desired with a separating material or achemical adapted to prevent adhesion of a subsequently applied coatingof rubber to the body. of the catheter, Aand then applying such acoating of rubberto form the distensible bag portion in situ andintegral with the main body of the catheter. The

bagportion of such a catheter, however, is not in fact a bag but ismerely a close-tting annular band of rubber which vis attached at bothedges to the body of the catheter, andwhen such a close-fitting bagportion is distended to the bulbous configuration required in use, therubber of the bag is necessarily greatly stretched. Thisv is undesirablefor several reasons. Considerable pressure is required to distend such abag and, upon distending, the rubber may not stretch uniformlythroughout the bag which produces an improperly shaped distended bag.I'he walls of 40 the distended bag are under relatively high tension andmay therefore fail by bursting or p uncture, with attendant danger tothe patient. If there is any appreciable lamination in the body of thecatheter, the pressure and tension may pull the rubber layer forming thebag loose from the underlying rubber at theedges of the bag which, ofcourse, would result at least in an improperly shaped bag, and in manycases, would completely ruin the catheter for further use.

Many of these undesirablev features may be eliminated by forming the bagas a separate part with a desired bulbous configuration and attachingthe pre-formed `bulbous bag to the body of a suitable double-channeledrubber catheter as described in my co-pending application Ser. No.

(Cl. 12S-349) 163,422, filed September 11, 1937, but many surgeonsprefer an integral bag formed in situ, feeling that an integralone-piece structure is less likely to fail in use.

The present invention accordingly has for its 5 chief objects theprovision of a catheter or similar surgical accessory provided with adistensible bag formed in situ but which is pre-distended so thatminimum pressure and minimum stretching of the rubber will be requiredto t the bag to the l0 prostatic fossa of a patient, and the provisionof an economical efllcient method of making such an article,.-`Moregenerally, the invention aims to provide economy and eiiiciency inrubber surgical accessories and in the manufacture of 16 suchaccessories. Other objects will appear as the description of theinvention proceeds with reference to the accompanying drawing of which:Fig. l is a sectional elevation illustrating the initial step in apreferred process of manufac- 20 turing distensible bag cathetersaccording to the `present invention and showing complementary broken.away for clarity of illustration, showingl 35. I

the catheterafter application of the bag-forming coat of rubber.

Fig. 7 is a sectional elevation illustrating later steps in the processand showing the preferred procedure of drying and vulcanizing thecatheter 40 while the bag is distended.

Fig. 8 is an elevation, partially broken away for clarity ofillustration.' showing a finished distensible bag catheter made inaccordance with the present invention. 4

In manufacturing a distensible bag catheter according to a preferredprocedure illustrative of the present invention, I utilize complementarydeposition forms I0 and li for producing the double-channeled body ofthe catheter. The 50 principal or drainage tube form l0 preferablyshould be a circular rod provided with a longiv tudinal groove, whilethe auxiliary or distensionduct form Il should preferably be a wire orrod of relatively small diameter adapted to t in the 55 groove of thedrainage tube form III and having Y an offset extension as shown. v.

In the process, the deposition forms III and II are .individually coatedwith rubber, asby immersing the forms to a suitable depth in a liquidrubber composition I2 contained in a tank- I3 and depositing coatings ofrubber, designated Ila and I 4b respectively, upon the forms I0 and II.Theliquid rubber compositionA I2 may be a solution of rubber in asuitable solvent such as the j Patent No. 1,924,214 to facilitatestripping the Y deposited rubber from the forms.

When the rubber deposits Ila, Ilb, have solidified sufciently to permithandling, the coated forms I0, II are assembled by placing the coatedauxiliary form I'I in the groove of the coated principal form Ill andlpressing the fresh rubber deposits tightly together, cohesion of theunvulv canized rubb'er'deposits'v usually being suflicient to hold Vthecoated forms in proper relation for further handling. -fl'lhe assembledcoated forms are then Iimmersed in the liquid rubber composiy tion I2and anfadditional overall coating of rubber is deposited uponth'eassembly, the additional deposit merging withvthe previous deposits toform an integral vdeposit designated llc (Fig. 5)..

After the deposit llc has become firmly set, but before it is'driedbeyond the point at which satisfactory cohesion ofV a subsequentlyapplied rubber deposit may be obtained, a small opening y I5 is cut inthe rubber overlying the auxiliary form II at a point near the'distalendof the form, thereby providing communication into lthe distensionduct produced in the body of the catheter by the form Il, and acircumferential zone Iii of the rubber deposit llc, about one or twoinches wide and including the opening I5, is

treated to prevent cohesion of a subsequently applied rubber ldepositwith the deposit llc.. For example, the circumferential zone I6 may betreated with a suspension of a pulverulent separating material such-assoapstone in alcohol, preferably containing :1 -latex coagulant if latexis being used, or itfmay bel-treated with bromine or chlorine in asuitablesolvent, or otherwise4 treated to render the local zone I6 ofthe rubber non-adhesive, such .procedures being well-known.

mersed in thev liquid rubber composition I2y and an additional overallthinlcoating of rubber about 0.015inch'thick is' produced upon theassembly, this coating merging with the lformer rubber, deposits toproduce an integral rubber structur Md except-over the treated'zone I6where the nal coating forms Va- Vseparate circumferential vband I1constituting .a distensible bag portion.

'I'he product at this stage of manufacture is thoroughly washed forseveral hoursin running water andthen is allowed to stand'for about anhour at room temperature to effect-superficial drying of the rubber. Theauxiliary form Il .iS

then ,removed from the rubber deposit, and a measured quantity of air isinjected through the distension duct IB produced by the form II, as witha calibrated syringe, to distend the bag II to the desired extentapproximating the maxlmumdistension to be required of the bag in use,

and the distension duct is thenvclosed as by inserting a stopper I9 inthe open end f the duct. For the usual size hemostatic bag catheter, to50 cc. of air ordinarily are injected. The catheter with the bagdistended is then subjected to conventional drying and vulcanizingtreatments (Fig. '1) as by hanging the catheter (while still on theprincipal form I 0) in an oven 20 and circulating hot air at atemperature of 150 F. for eight hours and then raising the temperatureto vulcanizing temperatures for an appropriate time to eifectvulcanization of the rubber, these factors depending, of course, uponthe particular rubber o. composition being used. If desired, the drying'may be completed before the bag is distended, but

it is preferred to effect substantially all the dryv ing as well as thevulcanization of the rubber is broadly termed in the art a pear-shapefor more closely fitting the prostatic fossa.

The drying and vulcanizing of the distended rubber bag relieves thetension in the rubber and fixes the bag in its distended condition sothat, when the bag is deated, the rubber walls of the bag do notcontract to their initial close-fitting extent but retain substantiallytheir distended extent, the bag collapsing and forming folds as shown inFig. 8 as a result of the increased extent of the walls.

Finally, the principal form III is withdrawn lfrom. the drainage tube22. formed thereby, the

ends of the tubes are trimmed, and drainage eyelets 23, 23 are out inappropriate positions distal to the bag I1, to produce the finisheddistensible bagA catheter illustrated in Fig. 8.

It is therefore seen that the distensible bag catheter producedaccording to the present invention has an integral one-piece structure,the distensible bag being lformed in situ and the walls ofthe bag. beingan integral continuation of outer portions 'of the mainbody of thecatheter, but tbat'the bag nevertheless has a pre-distended or presetconfiguration approximating the configuration ordinarily required in useso that minimum stretching of therubber bag accompanies it's'distension,thereby reducing the pressure required Vfor distension, eliminating thehigh strains in' previous'distended bags, and minimizing the danger offailure. Also the present invention provides, for the first time, anintegral bag formed in vsitu and having the highly desirable pear-shapefor-fitting the prostatic fossa. 'I'he bag walls retain their exibility,however, and the bag may caused to conform to cavities of various.

shapes. Also, the bag may be distended to sizes larger than thepre-distended or pre-set size, by injecting fluid under sulcientpressure to stretch the bag, and upon deflation, in such case, the bagwill again assume substantially the pre-set size and shape.

Numerous modiiications and variations in details of the procedure andmaterials as herein described may be effected without departing from thespirit and scope of the invention as deiined by the appended claims.

I claim:

1. A distensible bag catheter comprising a tubular rubber structureembodying a drainage tube and a distension duct having an openingleading through the wall of said structure, and a distensible bag uponthe tubular structure over said opening, whereby the bag may bedistended by injection of uid through said duct and opening, the wallsof said bag being integral continuations of the adjacent surfaceportions of the tubular structure but having a substantially greaterareal than the area of the tubular structure covered by the bag, wherebya loose-litting seamless bag is provided which may be distended to a.bulbous shape and size approximating the shape and size required inservice substantially without stretching the walls of the bag and whichmay be further distended to a larger bulbous shape and size withstretching of the said walls.

2. A surgical accessory comprising a tubular rubber structure, adistensible rubber bag upon said structure, and means for distending thebag by iniection of uid, the walls of said bag comprising a rubbermembrane constituting an unseamed, integrally and simultaneously formed,continuation of surface portions of the said tubular structure, saidmembrane having a predistended extent substantially greater than theextent of the portion of the tubular structure covered by the bag andbeing permanently set against recovery from said pre-distended extentbut retaining a capability for further extension from and recovery tosubstantially the said predstended extent.

3. An article of manufacture comprising a onepiece integral rubber bodyhaving a surface portion separated from an underlying portion of thebody in a determinate zone of substantial extent to provide asubstantially closed chamber between the two body portions, saidseparated surface portion comprising a rubber membrane having apre-distended extent substantially greater than the extent of theunderlying portion of the body and being permanently set againstrecovery from GEORGE L. WINDER.

